[Progress and Challenges in the Application of RhCE Models for Eye Irritation Evaluation of Medical Devices].

Abstract

Eye irritation evaluation is a critical component of the biocompatibility assessment of ophthalmic medical devices. Driven by the advancement of the "3R" principles for experimental animals, 3D reconstructed human cornea-like epithelium (RhCE) models have attracted considerable research interest as a prominent alternative to traditional Draize rabbit eye tests. This article analyzes the limitations of traditional animal testing and systematically reviews the construction principles, biological characteristics, and current application status of mainstream commercial RhCE models. Furthermore, the applications of evaluation metrics such as MTT tissue viability, transepithelial electrical resistance, and inflammatory cytokine release are discussed in detail. Finally, it explores the current regulatory acceptance status, challenges, and future prospects of RhCE models in medical device regulation, providing a reference for the development of in vitro biological evaluation methods for medical devices in China.